A Study to Test the Effects of Nezavist at Different Doses in Healthy Adults
Summary
The goal of this clinical trial is to determine the safety, tolerability and effects of Nezavist in healthy adults. The main questions it aims to answer are: * What is the safety and maximum tolerated dose (MTD) of orally administered Nezavist formulated as a spray dried dispersion (SDD) in healthy volunteers? * What are the pharmacokinetics (PK) of orally administered Nezavist SDD and its major metabolite (DCUKA) across a range of doses in healthy volunteers? Researchers will compare the active drug (Nezavist) and a placebo (an inactive substance that looks like the drug) to see if there is any differences between the two groups to make sure Nezavist is safe to use in future studies for reducing alcohol consumption by individuals that have alcohol use disorder (AUD).
Timeline
- Start
- 2025-02-28
- Primary completion
- 2027-04-01
- Completion
- 2027-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nezavist | Unknown | 500 mg | Oral |
| Subject | Nezavist | Unknown | 1500 mg | Oral |
| Subject | Nezavist | Unknown | 4500 mg | Oral |
| Subject | Nezavist | Unknown | 13500 mg | Oral |
Indications
No indication recorded.